How do we keep medicines safe and working properly?

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How do we keep medicines safe and working properly?

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In this explainer episode, Rachel Brucoli, Deputy Director at the Medicines and Healthcare products Regulatory Agency, explains how we make sure that medicines stay safe and work properly. You can also find a series of short videos explaining some of the common terms you might encounter about genomics on our YouTube channel. If you’ve got any questions, or have any other topics you’d like us to explain, let us know on podcast@genomicsengland.co.uk. Read more about the MHRA via their website. You can download the transcript or read it below. Florence: How do we make sure that our medicines stay safe and work properly? My name is Florence Cornish, and today I'm joined by Rachel Brucoli, who is a Deputy Director at the Healthcare products Regulatory Agency, also known as the MHRA. And Rachel is here to tell us much more about the topic Well, firstly, Rachel, thank you so much for joining us today. It's great to have you on. Rachel: Thank you. Nice to be here. Florence: The first question I wanted to ask you is quite a big question and I guess the crux of this entire episode really. Um, but how do we ensure that medicines are safe and work properly before they get to patients? Rachel: Yeah, it's an important question, isn't it? So in the UK, medicines are regulated by the Medicines and Healthcare Products Regulatory Agency or MHRA for short. And that's to ensure they, they are safe, they work correctly in a specified disease, and they're made to a high standard before they reach the public. In line with the relevant law, which is the Human Medicines Regulation, before a medicine is allowed to be placed on the market in the UK, the MHRA reviews safety information from clinical trials to ensure that the medicine does not cause unexpected or unacceptable effects. We also review efficacy data from clinical trials to make sure that the medicine works in the disease or condition and in the patient population that the manufacturer claims it does. Um, another important aspect that's reviewed is how the medicine's manufactured. It's very important that the medicine is made consistently and that every batch meets agreed specifications. Florence: And so you used that word regulation a few times. When we say that medicines are regulated, how do we do that? What does that process actually look like? Rachel: Yeah. So different countries have different laws that govern how medicines are regulated. And as I mentioned before, in the UK, the relevant legislation is the Human Medicines Regulations. In addition, different countries have different pathways or procedures for licensing of medicines, but it's worth noting that the types of data looked at by regulators is similar, and we've got harmonised standards in, in many respects. In the UK, different types of application can be submitted depending on the type of medicine under review. So for example, the data submitted for a brand-new medicine containing a new active substance that hasn't been approved in the UK would differ from that submitted for a generic medicine. The licensing process is triggered when a marketing authorisation application is submitted to the MHRA by a pharmaceutical company or a biotech company. And for new medicines, this application contains a significant amount of data that's been generated over, um, a large number of years. Florence: Mm-hmm. Can you tell us a little bit more about that? What types of information are submitted to you in this process? Rachel: Yes. So there's three main types of information that, that we receive. Um, the first is quality data, and that provides evidence that the medicinal product can be made safely, reliably, and to a high standard. It describes what the medicine's made of, how it's made, and provides evidence that the medicine can be produced consistently. The second body of data contains the results of the non-clinical studies, and there they characterize the pharmacology, and the safety profiles of the active ingredient of the medicine. And the third section of the application is the results and analyses of all the clinical studies conducted with the proposed medicine. These clinical studies will have been conducted in phases, and they're designed to determine the optimal dose of the medicine needed to treat the specific disease and to provide evidence that the medicine works, or as we would say, is efficacious, and that's usually compared to placebo. So, what's being measured in clinical studies are clinical endpoints, and they are specific outcomes or events that are measured to determine if a new treatment works. So, I guess giving an example of that is a cancer medicine, um, where a relevant endpoint that could be measured might include overall, an increase in overall survival or a reduction in tumour size. Additionally, some other important, outcomes could be patient-reported, such as effects on quality of life. So these clinical data will be analysed using appropriate statistical methods, and then ...

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